Teva Pharmaceuticals Announces Phase 2/3 and 3 Trials of Deutetrabenazine in Pediatrics with Tourette Syndrome Did Not Meet the Primary Endpoint

Teva Pharmaceuticals Announces Phase 23 and 3 Trials of Deutetrabenazine in Pediatrics with Tourette Syndrome Did Not Meet the Primary Endpoint

Teva Pharmaceuticals announced the Phase 2/3 ARTISTS 1 and Phase 3 ARTISTS 2 trials designed to evaluate deutetrabenazine compared to placebo for the treatment of tics in pediatric patients with moderate to severe Tourette Syndrome failed to meet the primary endpoint of reduction in motor and phonic tics as assessed by the Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS).

ARTISTS 1 was a multicenter, randomized, double-blind, placebo-controlled, Phase 2/3 study to evaluate the safety, tolerability and efficacy of deutetrabenazine in 119 pediatric patients (6-16 years) with moderate to severe Tourette Syndrome. Patients received either deutetrabenazine or placebo using a 1:1 randomization over 12 weeks of dosing. The primary endpoint was the change in the Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS) from baseline to week 12 between placebo and active treatment groups. 

ARTISTS 2 was a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study to evaluate the safety, tolerability and efficacy of deutetrabenazine in 158 pediatric patients (6-16 years) with moderate to severe Tourette Syndrome. Patients received either deutetrabenazine (low dose or high dose) or placebo using a 1:1:1 randomization over eight weeks of dosing. The primary endpoint was the change in the Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS) from baseline to week eight between placebo and active treatment groups. 

About Austedo (deutetrabenazine)

Austedo is a vesicular monoamine transporter 2 (VMAT2) inhibitor. It has been approved by the U.S FDA for the treatment of tardive dyskinesia in adults and for the treatment of chorea associated with Huntington’s disease. 

About Tourette Syndrome 

Tourette Syndrome is a neurodevelopmental disorder with onset before age 18 years, characterized by motor and phonic tics that persist for greater than one year. Symptoms of Tourette Syndrome typically occur first in early childhood, with peak severity around the age of 10 years. Most individuals with Tourette Syndrome experience improvement of symptoms in late adolescence and into adulthood.

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